Allergic RhinitisNCT00775658
Olopatadine Eye Drops and Allergy Skin Testing
A study testing olopatadine in people with Allergic Rhinitis and Allergic Conjunctivitis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Conjunctivitis
- What is being tested?
- olopatadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years
- Healthy volunteers (no major illnesses or active symptoms)
Who cannot join
- Known allergy or hypersensitivity to the drugs or components
- Pregnant or nursing women
- Women wishing to become pregnant during the study's duration
- Use of topical or oral medications with antihistaminic activity for 14 days proceeding randomization
- Dermatographism as evidenced on skin testing on visit 1
- Chronic urticaria active within the past 6 months
Show all 9Show fewer
- Severe hypertension
- Psychiatric diagnoses which could potentially affect medication compliance, such as schizophrenia or delusional disorders, as determined by the investigator obtaining informed consent and based on the subject's past medical history
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Asthma, Sinus and Allergy Program Research
Nashville, Tennessee, 37203
About this study
Official title: Effect of Olopatadine Hydrochloride 0.2% Ophthalmic Solution on Epicutaneous Skin Prick Testing With Histamine and Saline
Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity.
- Conditions
- Allergic Rhinitis, Allergic Conjunctivitis
- Being tested
- olopatadine, placebo
- Keywords
- allergy, skin testing, eye drops, antihistamines
- Medical subject headings
- Rhinitis, Allergic, Conjunctivitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olopatadineDrug
olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day
placeboDrug
placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day
| Study group | Role | What they receive |
|---|---|---|
| olopatadine then placebo | Active comparator | participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days Receives: Drug: olopatadine; Drug: placebo |
| placebo then olopatadine | Active comparator | participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days Receives: Drug: olopatadine; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
Measured: at baseline and at return visit (between study day 7-10)
The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
Measured: at baseline and at return visit (between study day 7-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Michael Fahrenholz, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775658
- Sponsor's protocol ID
- 071260
- Status last verified
- Jun 2017
- First submitted
- 17 Oct 2008
- Last updated
- 12 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Olopatadine Hydrochloride 0.2% Ophthalmic Solution on Epicutaneous Skin Prick Testing With Histamine and Saline
- ClinicalTrials.gov ID
- NCT00775658
- Acronym / sponsor ID
- 071260
- Conditions
- Allergic Rhinitis, Allergic Conjunctivitis
- Keywords
- allergy, skin testing, eye drops, antihistamines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Posted 12 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olopatadine then placebo | Active comparator | Drug: olopatadine, Drug: placeboparticipants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days |
| placebo then olopatadine | Active comparator | Drug: olopatadine, Drug: placeboparticipants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 to 75 years
- Healthy volunteers (no major illnesses or active symptoms)
Key exclusion criteria (9 listed)
- Known allergy or hypersensitivity to the drugs or components
- Pregnant or nursing women
- Women wishing to become pregnant during the study's duration
- Use of topical or oral medications with antihistaminic activity for 14 days proceeding randomization
- Dermatographism as evidenced on skin testing on visit 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olopatadineolopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day | Drug | olopatadine then placebo, placebo then olopatadine |
| placeboplacebo, normal saline opthalmic solution 1 drop into each eye at the same time each day | Drug | olopatadine then placebo, placebo then olopatadine |
Primary outcome
The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
Time frame: at baseline and at return visit (between study day 7-10)
The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
Time frame: at baseline and at return visit (between study day 7-10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olopatadine in people with Allergic Rhinitis and Allergic Conjunctivitis, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo. (time frame: at baseline and at return visit (between study day 7-10)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.